Understanding Balance Impairment in COPD

Healthy Volunteers Clinical Trial

Official title:

An Investigation of the Physiological and Psychosocial Mechanisms Underpinning Balance Impairment in People With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984498
• Other study ID #: 2022 Aug 10959 Harrison
• Secondary ID: NIHR300856
• Status: Recruiting
• Start date: July 17, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: August 2023
• Source: Teesside University
• Contact: Kirsti J Loughran, PhD
• Phone: 01642 342934
• Email: k.loughran[@]tees.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is an observational study investigating the mechanisms of balance problems in people with COPD and how COPD impacts them living their daily lives.

The main objectives of this study are:

• To quantify the relationship between balance and aspects of neuromuscular function in individuals with COPD, and compared to age-matched healthy controls

• To understand the lived experience of people with COPD and their carers

Participants will attend an appointment at the University rehab lab to:

• Complete a balance test

• Fill out some questionnaires on mood, health status and balance and falls

• Complete some walking tests

• Have their body composition measured

• Have the function and strength of their leg nerves and muscles tested Researchers will compare people with COPD and healthy controls (older adults without COPD or other conditions known to impact balance) to see if any of the things measured are impacting the balance of people with COPD more than their peers without COPD.

• For 10 people with COPD only they will be visited at home to observe how they carry out everyday tasks and 5 of those 10 will have a follow up interview.

Researchers will take notes and record interviews and look for similarities and interesting points in the notes and transcripts of the interviews to build a picture of what living with COPD is like.

Description:

Chronic obstructive pulmonary disease (COPD) is a progressive condition that affects around 1.2million people in the UK. Breathlessness is the main symptom but people with COPD are also more likely to fall than healthy people of the same age. Falling has emotional consequences, such as feelings of shame, embarrassment and fear of falling in public which leads to avoidance of outdoor activities. Researchers do not know why people with COPD fall more but they have poor balance which may, in part, be due to problems with sensory and muscle responses that would usually maintain balance. Symptoms of breathlessness and pain, plus inactivity, may further impact balance. Physical and social environments may also have a role in falls risk, but this has yet to be investigated. Pulmonary Rehabilitation (PR) which includes stamina and strength exercises, alongside education and emotional support is standard treatment for COPD but it does not include any balance exercises, meaning people with COPD who are at a greater risk of falling do not receive any routine treatment to improve balance. This study aims to investigate the physical, psychological, social and environmental factors impacting on balance in people with COPD by comparing them to older adults without COPD. The study will recruit from local hospital services (people with COPD and their carers without COPD) and within the community (healthy older adults). Balance, muscle function (size, strength and speed of nerve conduction) and physical activity will be measured, and the two groups compared. Researchers will also observe patients in their own homes and do follow up interviews to understand what it is like to live with COPD and the challenges people face. The information from this study will be used in conjunction with stakeholders to co design an intervention to improve balance in people with COPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

COPD

• Have a spirometry confirmed diagnosis of COPD as per GOLD guidelines

• Stable COPD (six weeks clear of exacerbation)

• 55 years or over at the point of recruitment

• Able to communicate with good verbal English or use adaptive equipment to communicate

• Male or female Controls

• Free from a diagnosis of COPD (confirmed by spirometry)

• 55 years or over at the point of recruitment

• Able to communicate with good verbal English or use adaptive equipment to

• Communicate

• Male or female

Exclusion Criteria:

COPD

• Recent exacerbation of COPD (within the last six weeks)

• Under 55 years of age at the point of recruitment

• Any neurological or musculoskeletal diagnoses (e.g., strokes, Parkinson's disease or chronic pain that interferes with ability to safely complete the tests

• Unable to provide written informed consent

• Unable to speak English or no translation options available

• Diagnosed but not corrected visual, vestibular disturbance and peripheral neuropathy

• Vasovagal syncope

• Not independent living (e.g., living in a care home or prison) Controls

• Abnormal lung function (FEV1 and FVC equal to or greater than 80% and FEV1/FVC equal to greater than 70%)

• Under 55 years of age at the point of recruitment

• Any neurological or musculoskeletal impairment that would significantly affect balance impacting ability to safely complete the assessments

• Unable to provide written informed consent

• Unable to speak English or no translation options available

• Any uncorrected visual or somatosensory disturbance

• Vasovagal syncope

• Living in a care home or in prison

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Healthy Volunteers
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Teesside University	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance Evaluation Systems Test (BESTest)	27 functional tasks scored on a 0-3 scale to give an overall percentage out from a maximum of 108 points. Higher scores indicate better balance.	baseline only
Secondary	The Activities- Specific Balance Confidence Scale (ABC)	A questionnaire that assesses confidence for performing 16 activities without a loss of balance. Scores for each item range between 0 (not confident) and 100% (completely confident). The total score for each item is divided by the number of items (16).	baseline only
Secondary	The Elderly Falls Screening Test	A questionnaire and test that involves three questions relating to falls history in the previous 12-months and a gait speed and pattern assessment over a 5-meter course to establish falls risk. Score out of 5 with higher scores indicating a greater risk of falls.	baseline only
Secondary	Incremental Shuttle Walk Test	A walking test where participants walk between two cones that are 10 meters apart to a increasingly frequent paced beep to measure exercise capacity. The diatnace walked is reported to the nearest 10m.	baseline only
Secondary	COPD Assessment Test	A questionnaire measuring COPD health related quality of life. Scored between 0 and 40 with higher scores indicating the greatest impact of COPD on quality of life.	baseline only
Secondary	Medical Research Council Dyspnoea Scale	A one question scale (0-4) of the impact of breathlessness with higher scores indicating greater impact of symptoms.	baseline only
Secondary	Lung function testing (spirometry) Forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FEV1/FVC)	A measure of lung function used to define COPD. Participants blow into a handheld spirometry device. FEV1 and FEV1 / FVC will be recorded.	baseline only
Secondary	Patient Health Questionnaire-9 (depression)	A one page questionnaire that measures symptoms of depression and low mood. Scored out of 27 with higher scores indicated greater symptoms of depression.	baseline only
Secondary	Generalised Anxiety Disorder-7 Questionnaire (anxiety)	A one page questionnaire that measures symptoms of anxiety. Scored out of 21 with higher scores indicating worse symptoms of depression.	baseline only
Secondary	Brief Pain Inventory	A two page questionnaire that records pain, pain intensity, pain location and pain interference. It consists of 9 items which are rated 0-10 with higher scores indicating a greater severity of pain.	baseline only
Secondary	Somatosensory accuracy	Vibration sensation perception will be measured with a neurothesiometer device on both big toes.	baseline only
Secondary	Maximal Voluntary Contraction Strength	The maximal strength that participants can generate in their thigh and calf muscles will be measured with a biodex dynamometer	baseline only
Secondary	Voluntary Activation Test	The amount of muscle available on top of a voluntary contraction in the quadriceps muscle will be measured using the biodex dynamometer and an electrical stimulus over the thigh muscles (Interpolated Twitch Technique)	baseline only
Secondary	Hoffman's Reflex	The speed and size of nerve response to a stimulus that mimics balance reactions will be measured in the tibial nerve by placing a small bar over the back of the knee that gives an electrical stimulus to the nerve.	baseline only
Secondary	Maximum grip strength	Participants hold a handheld dynamometer in their hands and squeeze the device to measure grip strength.	baseline only
Secondary	Physical Activity Monitor	Participants will be asked to wear a watch sized device (Actigraph Physical Activity Monitor) on their wrists for 7 days. The actigraph device measures levels of physical activity	baseline through to 7 days
Secondary	EuroQOL-5D-5Level	The EQ-5D-5L descriptive system comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) and each dimension has five response levels (no problems to unable/severe problems). Responses form a 5 digit code.; no problems, slight problems, moderate problems, severe problems, unable to /extreme problems.	baseline only
Secondary	Bioelectrical impendence analysis to record whole body composition of muscle, bone and fat	A bioelectrical impedance device (Tanita BIA) will record measures of body composition	baseline only